Trial Outcomes & Findings for Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology (NCT NCT01940354)
NCT ID: NCT01940354
Last Updated: 2017-11-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
220 participants
Primary outcome timeframe
Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
Results posted on
2017-11-09
Participant Flow
Enrollment occurred from April 2013 - November 2013. Location was Interventional Radiology Department at participating hospital.
Participant milestones
| Measure |
Vascular Access Via Study Device
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
110
|
|
Overall Study
COMPLETED
|
106
|
108
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Vascular Access Via Study Device
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
Baseline characteristics by cohort
| Measure |
Vascular Access Via Study Device
n=110 Participants
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
n=110 Participants
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
81 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
152 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
73 Participants
n=93 Participants
|
70 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
110 participants
n=93 Participants
|
110 participants
n=4 Participants
|
220 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutesOutcome measures
| Measure |
Vascular Access Via Study Device
n=110 Participants
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
n=110 Participants
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
|---|---|---|
|
First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
|
84 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutesPopulation: The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 6 in Study Device arm and n = 1 in the Control Arm).
Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable
Outcome measures
| Measure |
Vascular Access Via Study Device
n=104 Participants
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
n=109 Participants
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
|---|---|---|
|
Patient Satisfaction Upon Successful PIV Placement
|
3.88 units on a scale
Standard Deviation 1.11
|
4.46 units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutesPopulation: The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 5 in Study Device arm and n = 1 in the Control Arm).
Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: "How easy was the AccuCath™ System to use in comparison to the current catheter?" 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use
Outcome measures
| Measure |
Vascular Access Via Study Device
n=105 Participants
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
n=109 Participants
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
|
|---|---|---|
|
Clinician Satisfaction Upon Successful PIV Placement
|
3.27 units on a scale
Standard Deviation 1.11
|
3.48 units on a scale
Standard Deviation 1.04
|
Adverse Events
Vascular Access Via Study Device
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Vascular Access Via Control Device
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vascular Access Via Study Device
n=110 participants at risk
AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal.
AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
|
Vascular Access Via Control Device
n=110 participants at risk
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal.
Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
|
|---|---|---|
|
Vascular disorders
Infiltration
|
1.8%
2/110 • Number of events 2 • Adverse event data were collected for each participant from post-PIV placement until catheter removal (up to 14 days).
|
7.3%
8/110 • Number of events 8 • Adverse event data were collected for each participant from post-PIV placement until catheter removal (up to 14 days).
|
|
Vascular disorders
Hematoma
|
0.00%
0/110 • Adverse event data were collected for each participant from post-PIV placement until catheter removal (up to 14 days).
|
2.7%
3/110 • Number of events 3 • Adverse event data were collected for each participant from post-PIV placement until catheter removal (up to 14 days).
|
Additional Information
Scott Trerotola, MD
Hospital of the University of Pennsylvania
Phone: 215-662-6983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place